Proposed Rule: New Required Warnings for Cigarette Packages and Advertisements
FDA’s proposed rule, "Required Warnings for Cigarette Packages and Advertisements,” would require new cigarette health warnings with color images on cigarette packages and in cigarette advertisements to promote greater public understanding of the negative health consequences of smoking.
Submit comments on the proposed rule by October 15, 2019.
On this page:
- Statistics about Cigarette Use
- FDA Regulation of Cigarettes
- Manufacturing Cigarettes
- Retail Sales of Cigarettes
- Importing Cigarettes
- Reporting Adverse Experiences and Product Violations
The basic components of most cigarettes are tobacco, chemical additives, a filter, and paper wrapping. Cigarettes are responsible for the vast majority of all tobacco-related disease and death in the United States. Smokers are exposed to a toxic mix of over 7,000 chemicals when they inhale cigarette smoke.1 The harmful chemicals in cigarette smoke can damage nearly every organ in the body.2 Nonsmokers are exposed to many of these same chemicals through secondhand smoke.
- Every day, on average, about 2,000 youth under age 18 smoke their first cigarette and more than 300 youth under age 18 become daily smokers.3
- Nationwide, 7.6 percent of high school students (1.2 million) and 2.1 percent of middle school students (250,000) currently smoke cigarettes.4
FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of cigarettes, including components, parts, and accessories, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.
In July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death, including pursuing lowering nicotine in cigarettes to non-addictive levels.
“Heated tobacco products” and “heat-not-burn tobacco products” are colloquial terms that do not appear to have universally agreed upon definitions and seem to be used interchangeably. For the FDA’s purposes, if a tobacco product meets the legal definition of a cigarette but the tobacco is not heated to a temperature high enough to cause combustion, the product would be currently categorized as a “non-combusted cigarette” and regulated as a cigarette.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import cigarettes, you must comply with these requirements for manufacturers.
CTP’s Office of Small Business Assistance can answer specific questions about requirements of small businesses and how to comply with the law. This office also provides online educational resources to help regulated industry understand FDA regulations and policies.
If you sell cigarettes, please read this summary of federal rules that retailers must follow. In addition, our website provides more information on regulations, guidance and webinars for retailers.
Click on the flyer thumbnail image to order printed materials from CTP's Exchange Lab or to download a PDF to print yourself.
Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). You can find more information on the Importing and Exporting webpage.
You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.
If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported.
If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report your adverse experience to FDA. Knowledge about adverse experiences can help FDA identify health or safety issues beyond those normally associated with product use.
If you believe these products are being sold to minors, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, report the potential violation.
1. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: How Tobacco Smoke Causes Disease: What It Means to You (Consumer Booklet). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.
2. U.S. Department of Health and Human Services (USDHHS). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.
3. Substance Abuse and Mental Health Services Administration (SAMHSA). 2017 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral Health Statistics and Quality; 2018. https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf. Accessed October 12, 2018. (Original Data Source: NSDUH 2017, Table 4.10A)
4. Wang TW, Gentzke A, Sharapova S, et al. Tobacco Product Use Among Middle and High School Students – United States, 2011-2017. MMWR Morb Mortal Wkly Rep. 2018; 67:629–33.